BEUDAMED
    29 results · 23ms · Sources: EU EUDAMED, US FDA

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    ABACUS TM SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MIRABAY

    FDA UDI
    Mirabay Orthodontics Corp.·05061075026727·OPEN COIL SPRING STAINLESS .010X.036 40INCH SPOOL

    ZAVATION F3D-Z CIF

    FDA UDI
    Zavation LLC·00197157020859·F3D-Z CIF 16mmx18mmx7mm - 0deg

    Merit® Kit

    FDA UDI
    Merit Medical Systems, Inc.·00884450278222·

    ZEUS-O

    FDA UDI
    SPINAL ELEMENTS·00840606151382·ZEUS®-O 7MM DILATOR

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K1100070·Tray Insert 1, NIDO

    INTERFERENTIAL STIMULATOR, MODEL BMLS02-6

    FDA 510(k)
    FDA Class 2 ·Neurology

    SLEEP PROFILER

    FDA 510(k)
    FDA Class 2 ·Neurology

    CLEARLINK PACLITAXEL SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·February 2, 2024

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 3, 2014

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC·Product code CBK·May 28, 2013

    RHEUMATOID FACTOR TEST SYSTEM

    FDA Adverse Event
    Injury ·BECKMAN COULTER INC.·Product code DHR·June 25, 2011

    CLEARLINK SOLUTION ADMINISTRATION SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·April 27, 2022

    Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·March 28, 2018

    CLEARLINK SOLUTION ADMINISTRATION SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·April 27, 2022

    Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code OJV·September 20, 2017

    Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code OJV·September 20, 2017

    Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·March 28, 2018

    BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·November 26, 2018

    UNKNOWN JOINT REPAIR DEV

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBI·January 6, 2026